OpenOnco v0.1.2 · 2026-04-30
OpenOnco · DIS-UROTHELIAL · BIO-FGFR2 (ESCAT IB)
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Treatment plan — DIS-UROTHELIAL
PLAN-BMA-FGFR2_MUTATION_UROTHELIAL-V1 · v1 · 2026-05-04
Patient
BMA-FGFR2_MUTATION_UROTHELIAL · Algorithm: ALGO-UROTHELIAL-METASTATIC-1L

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
BIO-FGFR2activating mutation (FGFR2 fusion or kinase-domain mutation)IB
  • SRC-CIVIC: Level B (Supports, Sensitivity/Response)
  • SRC-CIVIC: Level C (Supports, Sensitivity/Response)
  • SRC-CIVIC: Level D (Supports, Sensitivity/Response)
FGFR2 fusion / activating mutation in metastatic urothelial carcinoma: erdafitinib (BLC2001, Loriot NEJM 2019 — ORR 40%; THOR phase 3, Loriot NEJM 2023 — OS HR 0.64 vs chemo) is FDA-approved for FGFR2/3-altered locally advanced or metastatic urothelial 2L+. FGFR2 alterations less common than FGFR3 in urothelial (~3% vs ~15%).erdafitinib monotherapy (2L+ post-platinum / post-IO)
  • SRC-NCCN-BLADDER-2025
  • SRC-EAU-BLADDER-2024

Treatment options (2 tracks)

Aggressive plan
★ DEFAULT
Indication
IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO-AVELUMAB
Regimen
Cisplatin + gemcitabine (urothelial neoadj + metastatic)
Drugs + NSZU
  • Cisplatin (DRUG-CISPLATIN) 70 mg/m² IV · Day 1 of 21-day cycle · IV ⚠ NSZU — not for this indication
  • Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² IV · Days 1, 8 of 21-day cycle · IV ⚠ NSZU — not for this indication
Reason
Engine default per algorithm ALGO-UROTHELIAL-METASTATIC-1L: {'step': 2, 'outcome': False, 'branch': {'result': 'IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO-AVELUMAB', 'notes': 'Cisplatin-ineligible + EV-pembro ineligible: gemcitabine+carboplatin (4-6 cycles) → avelumab maintenance. IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO- AVELUMAB covers both cisplatin and carboplatin backbone — regimen selection guided by CrCl and patient fitness within the indication.\n'}, 'fired_red_flags': [], 'winner_red_flag': None}
Standard plan
Indication
IND-UROTHELIAL-METASTATIC-1L-EV-PEMBRO
Regimen
Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L)
Drugs + NSZU
  • Enfortumab vedotin (DRUG-ENFORTUMAB-VEDOTIN) 1.25 mg/kg IV · Days 1, 8 of 21-day cycle · IV ✗ Not registered in UA
  • Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w · Up to 2 years · IV ⚠ NSZU — not for this indication
Reason
Alternative track presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-CECT-CAPCECT chest/abdomen/pelvisCriticalimagingall tracks

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Cisplatin + gemcitabine (uroth
21-day cycles × 4 cycles neoadj; 6 cycles metastatic

Standard plan

Induction · Enfortumab vedotin + pembroliz
21-day cycles × EV until progression; pembro up to 2 years

MDT brief

Skills (recommended) — for consideration (1)

  • Clinical pharmacist recommended
    Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
    skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Open questions (1, 0 blocking)

  • OQ-LDH-CURRENT
    What is the current LDH? Marker of tumor burden and transformation.
    LDH is part of the prognostic indices of indolent lymphomas.
    → hematologist

Data quality

  • Unevaluated RedFlags: RF-UROTHELIAL-FRAILTY-AGE, RF-UROTHELIAL-HIGH-RISK-BIOLOGY, RF-UROTHELIAL-INFECTION-SCREENING, RF-UROTHELIAL-ORGAN-DYSFUNCTION, RF-UROTHELIAL-TRANSFORMATION-PROGRESSION

Skill catalog (1/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-04.
NCTTitlePhaseStatusSponsorUAEligibility (excerpt)
NCT06632262A Phase 2 Clinical Study of ABSK061 and ABSK043PHASE2RECRUITINGAbbisko Therapeutics Co, Ltd

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
OptionUA registrationNSZUCost orientationAccess pathway
Aggressive plan
Cisplatin + gemcitabine (urothelial neoadj + metastatic) (REG-CISPLATIN-GEMCITABINE-UROTHELIAL)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Standard plan
Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L) (REG-EV-PEMBRO-UROTHELIAL)
1/2 component drug(s) not registered in Ukraine +1
✗ not registered✗ out-of-pocket₴-? — verify pathwaynot recorded
Trial · NCT06632262
A Phase 2 Clinical Study of ABSK061 and ABSK043
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-04.